S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma

Not Applicable

Completed

• Conditions: Stomach Neoplasms
• Interventions: Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium

• Registration Number: NCT01364376
• Lead Sponsor: Zhejiang University

Brief Summary

This is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus 5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative chemotherapy for advanced gastric cancer.

Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for advanced gastric cancer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-05-31
• Study Start: 2011-06
• Study First Posted: 2011-06-02
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-20
• Last Update Posted: 2016-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 583

Inclusion Criteria

• Histologically confirmed gastric adenocarcinoma,diagnosed as locally advanced gastric cancer and primary tumor invades or penetrates serosa
• Ambulatory males or females, aged 18-80 years old
• ECOG score 0-2
• Given informed consent
• Life expectancy more than 3 months
• Measurable lesion
• Normal cardiac, hepatic, renal, and bone marrow function(WBC:3.5×10^9/l~12×10^9/l;PLT:>100×109/l;Bil:<1.5 fold of upper limit value; ALT/AST:<2.5 fold of upper limit value;Ccr:>80ml/min;Cr:1.5mg/dl)

Exclusion Criteria

• Prior stomach surgery
• Previous cytotoxic chemotherapy, radiotherapy, target therapy or immunotherapy for any tumor
• History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
• distant metastasis(such as No.16 and No.13 lymphnode,liver, lung,brain,bones or peritoneal metastasis)
• Severe bleeding
• Bowel obstruction, ileus or complete pyloric obstruction
• Serious uncontrolled concomitant disease
• History of myocardial infarction in 6 months
• Woman with on-going pregnancy or breast-feeding, or contemplating pregnancy
• Systemic treatment with corticosteroid
• Patients judged inappropriate for the trial by the physicians

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOLFOX	S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium	-
SOX	S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium	-

Primary Outcome Measures

Name	Time	Method
overall survival	3-year

Secondary Outcome Measures

Name	Time	Method
progression-free survival(PFS)	3-year
clinical response	6 or 12 weeks
pathological response	within 10 days after surgery
Number of Participants with grade 3/4 adverse Events	6 Years

Trial Locations

Locations (8)

Jiaxing First Hospital; 🇨🇳 Jiaxing, Zhejiang, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China

Sir Run Run Shaw Hospital; 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliated Hospital of Medical School of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Medical School of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

Ningbo Medical Treatment Center Lihuili Hospital; 🇨🇳 Ningbo, Zhejiang, China

The second affiliated hospital of Wenzhou medical college; 🇨🇳 Wenzhou, Zhejiang, China